NCT02492776

A Multiple-Dose Pharmacokinetics Study of Two Gefapixant (AF-219/MK-7264) Formulations

A Study in Healthy Subjects to Assess the Multiple-Dose Pharmacokinetics of Two AF-219 Formulations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of two gefapixant (AF-219) formulations; to assess the effect of omeprazole on the multiple dose PK of two gefapixant formulations; and, to assess the safety and tolerability of gefapixant.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Omeprazole	20 mg oral capsules administered once daily for 8 days
DRUG	Gefapixant	Gefapixant oral tablet (25 mg administered as a divided 50 mg tablet) administered twice daily for 5 days
DRUG	Gefapixant	Gefapixant oral tablet (50 mg tablet) administered twice daily for 8 days

Timeline

• Start date: 2015-07-07
• Primary completion: 2015-08-04
• Completion: 2015-08-11
• First posted: 2015-07-09
• Last updated: 2022-07-22

Locations

1 site across 1 country: United States